US Guided Erector Spinae Plane Block in Breast Cancer Surgery: Analgesia, Spread and Immunomodulation

Breast Cancer Clinical Trial

Official title:

Ultrasound Guided Erector Spinae Plane Block in Breast Cancer Surgery: Analgesia, Spread and Immunomodulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04796363
• Other study ID #: Medical Research Institute
• Status: Completed
• Phase: N/A
• Start date: November 25, 2020
• Est. completion date: January 21, 2022

Study information

• Verified date: April 2022
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective interventional study

Description:

The aim of the present study is to evaluate the effect of US guided unilateral ESPB using different volumes of local anaesthetics on analgesic efficacy, dermatomal spread and immunomodulation in breast cancer surgery. The primary outcome is the analgesic efficacy of the different local anaesthetic volumes of ESPB. The secondary outcomes are the dermatomal dye spread and sensory coverage, immunomodulation and complications in breast cancer surgery. Immunomodulation will be assessed by measuring Natural killer cells cytotoxicity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 21, 2022
• Est. primary completion date: January 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:ASA physical status 1 or 2 scheduled for mastectomy under the effect of General Anaesthesia -

Exclusion Criteria:

1. Patient refusal.

2. Allergy or contraindication to any of the studied medications or anaesthetic agents.

3. Chronic opioid analgesic use.

4. Pregnancy.

5. Morbid obesity (BMI = 40 kg/m2).

6. Scoliosis or any vertebral anomalies or previous spinal surgeries.

7. Infection at the site of injection or any other contraindication for regional anaesthesia.

8. Duration of surgery more than 90 minutes.

9. Renal impairment.

Related Conditions & MeSH terms

• Analgesia
• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Erector Spinae Plane Block with Bubivacaine
Erector Spinae Plane Block with Bubivacaine 0.25% or 0.125% before breast cancer surgery
• Standard General Anaesthesia
Standard General Anaesthesia without ESPB

Locations

Country	Name	City	State
Egypt	Medical Research Institute, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Immunomodulation of ESPB	Immunomodulation of ESPB by measuring Natural Killer cells cytotoxicity. Samples of 1 ml of patients' peripheral blood will be collected on EDTA for flow cytometry to enumerate for both cytotoxic lymphocyte populations (NK cells and cytotoxic t lymphocytes (Ctls)). CD 56 will be used as a marker for NK cells, while CD 8 will be used as a marker for Ctls.; Cytotoxicity assay will be done by measuring the release of lactate dehydrogenase (LDH) from cells. Then ratio of LDH released specifically from NK cells will be correlated according to the results of flow cytometry.	Before ESPB and 24 hours after the block.
Primary	Analgesic efficacy of ESPB	Analgesic efficacy of Erector Spinae plabe block by measuring visual analogue scale which ranges from 0 to 10. 0 indicates no pain and 10 indicates maximum imaginable pain	Up to 24 postoperative hours
Secondary	Spread of the injected dye in Erector Spinae plane	5 ml of radio-contrast dye will be injected in Erector Spinae plane with different dose of Bupivacaine at the level of 4th thoracic vertebra then spread of the dye will be assessed by CT scan (for example dye spread to first thoracic vertebra level cranially and 9th thoracic vertebra caudally).; 3 D reconstruction of the image will be done then Craniocaudal spread of the contrast and spread to Paravertebral space, epidural space or rami of the spinal nerves will be assessed and recorded.	Patients will be imaged 15 minutes after the block and before induction of general anaesthesia and surgery.
Secondary	Dermatomal sensory coverage of ESPB	will be assessed by hyposthesia to cold sensation. Field of sensory block from T1 to T6 will be assessed bilaterally every 3 minutes for 15 minutes after deep ESPB using a piece of cotton soaked in iced water. The adequacy of sensory block T1-T6 will be determined before induction of general anaesthesia.	Assessment will be done bilaterally every 3 minutes for 15 minutes after ESPB.